An Overview of Our Cardiac Medical Device Expertise
Cardiac medical devices comprise one of the largest categories of medical devices by sales. They are second only to in-vitro diagnostic devices. Approximately one out of every ten medical devices made are cardiac devices. Ranging from small, implantable devices to large external machines, they are used to diagnose and treat heart diseases and related cardiovascular problems.
Cardiac medical devices perform a variety of functions. Some monitor the heart for arrhythmias, sometimes responding with actions to correct irregular beats. Others supplement the heart’s pumping action. Individual valves can be manufactured, as can artificial organs to replace the heart completely. Stents can be inserted to increase blood flow, while other appliances can reshape the chambers of the heart. Some cardiac medical devices work outside the body, taking over the cardiopulmonary responsibilities during surgery or providing emergency defibrillation.
All medical devices must be manufactured to precise standards. Because of their crucial functions, cardiac medical devices are subject to exacting regulations. And, if the device is implantable, it must meet the highest criteria of all.
Proven Process Devices
Proven Process designs and manufactures a wide range of cardiac medical devices, from small implantables to large external machines. One of the smallest implantables we manufacture is the totally implantable blood pressure monitor, a tubular, strain-gauge sensor. The device was designed to provide ongoing monitoring of blood pressure without causing significant disruption or alteration of hemodynamics. The design phase used computational fluid dynamics analysis to model blood flow and extensive finite element analysis to determine the optimal placement of the sensors. In order to avoid the need for adhesive bonds that could interfere with the performance of the pressure sensors, a proprietary thin-film process was developed to place the strain gauge directly on the sensor diaphragm.
Another category of cardiac medical devices we manufacture are instruments used to perform medical procedures related to the heart. The pressure-tipped heart needle is one such device. The increased usage of minimally invasive procedures has required a concomitant increase in the sensitivity of devices. When working on the epicardial tissue, the risk of puncturing the right ventricle is always present. We designed a dual-lumen cardiac needle that employed a sensor to determine the amount of pressure being applied by the operator. Because of the differential in the pressure needed to penetrate the epicardial and the pressure required to penetrate the ventricle, feedback from the sensor could be interpreted by software to indicate when the heart itself was in danger of being punctured. Because of the delicate nature of the instrument, laser welding assured proper connections between the dual lumens and the sensor.
An example of a large, external cardiac medical device is the pneumatic driver for a total artificial heart. (left) Proven Process set out to design a unit to power a commercially available temporary heart replacement. Unlike previous drivers, however, this one was to be portable, allowing it to be used in a variety of settings, including in-home settings for ambulatory patients. Whereas previous devices required connection to the hospital’s air supply, the new unit has its own pneumatic source. Multiple redundant systems and hot-swappable power supply ensured that the device would continue to function even in the event of component failure. The pneumatic driver also required the development of software to control its function, and the design of the component included a screen and integrated interface to allow operator interaction. Once the design was approved by the FDA, it was manufactured at our facility.
Standards and Regulations
Due to the critical nature of cardiac medical devices and their often prolonged contact with patients, the standards and regulations pertaining to such appliances are extensive. In addition to ISO 13485:2016, which covers all medical devices, standards specific to cardiac medical devices include:
- ISO 14708-1:2014 — Active implantable cardiac devices: general requirements for safety, marking, and information to be provided by the manufacturer
- ISO 14708-2:2012 — Cardiac pacemakers
- ISO 14708-5:2010 — Circulatory support devices
- ISO 14708-6:2010 — Particular requirements for active implantable medical devices intended to treat tachyarrhythmia
- ISO 27185:2012 — Cardiac rhythm management devices, symbols to be used with cardiac rhythm management device labels, and information to be supplied, and general requirements
- IEC 62304:2006 — Medical device software
ISO 14708-1:2014 provides standards for software, data security, and risk management. It covers active implantable devices as well as any external components associated with such devices. ISO 14708-2 covers devices to treat bradyarrhythmias, while ISO 14708-6 is for implants that address tachycardia, such as defibrillators. ISO 14708-5 regulates appliances like left ventricular assist devices that supplement the heart’s natural function. A separate standard, ISO 27185, stipulates the information to be provided with the devices, including required symbols on the device itself. Within the United States, additional regulations for medical devices are found in the Current Good Manufacturing Practices, which require appropriate quality control processes.
Design and Manufacture
Proven Process covers both the design and manufacturing stages of the cardiac medical device creation. We can design products that are to be manufactured at our facility or handle the design for clients who plan to create the product elsewhere. Some clients choose us to manufacture devices that have already designed. Whether we handle the design or manufacturing stage—or both—Proven Process has the expertise and capability to produce cardiac medical devices that perform at the highest levels.
The process of designing cardiac medical devices begins with an assessment of the client’s requirements. Is the device intended to correct a problem or assist in a procedure? Does it need to function actively or passively (i.e., does it have its own power supply or rely on the patient’s movement or gravity)? Does it operate internally, externally, or a mixture of the two? Will it perform its function once or be used multiple times? Is it intended to work over an extended period or be used only on an ad hoc basis? Does it require an electronic controller and, if so, will software be required to operate it. These questions—along with a host of others—give the design team the parameters with which to begin working on a solution.
The engineering phase produces the design of the project. In addition to making sure that the device functions properly and fulfills the project requirements, this stage also focuses on other vital issues. Construction materials must be selected and a supply chain developed. These must address not only the availability of the materials but also their suitability for the project, taking into account the nature of the cardiac medical device and its lifecycle. Manufacturing and maintenance costs must be calculated to determine the feasibility of the project, and risk management assessments have to be performed to anticipate any possible problems. Finally, the product must be prototyped for testing to ensure it meets the customer’s needs. This stage of the process is iteratively reworked until the device complies with all the project requirements.
The first stage of manufacturing is pilot manufacturing, which is intended to assess the intended manufacturing process. This allows potential problems that could lead to issues with quality or cost to be identified. Once the process has been refined, full-scale manufacturing of the cardiac medical device can begin. Proven Process uses cell manufacturing for most of its projects, allowing steps in the process to be isolated. This allows problems with any part of the operation to be identified and corrected without disrupting the entire process. During manufacturing, each task must be documented. This record not only provides the client with data that can be used to obtain device approval from the FDA but also furnishes evidence of compliance with standards governing manufacturing and quality control.
If the cardiac medical device requires software to manage its operation, this is developed during the production phase. IEC 62304 provides the international standards for medical device software, including processes for planning, designing, implementing, and testing software. The FDA publishes additional guidelines for software. Proven Process engineers program in most major languages, including C, C++, C#, Visual Basic, and assembly languages. We can also manufacture the printed circuit boards and flash program the integrated circuits for such devices.
When manufacturing and assembly are completed, the final operations are the packaging and shipping of the cardiac medical device. These stages carry their own set of concerns. Packaging must provide information on the use and maintenance of the device as stipulated by international standards and FDA regulations. The packaging must also provide appropriate protection during shipping and storage. Cardiac medical devices can be delicate and must be insulated from temperature and barometric pressure changes and other meteorological concerns. The packaging also needs to protect the device against physical forces, including impacts and vibrations generated during transportation. Some devices will need to maintain sterility until used. The expected storage time between manufacture and use will also impact the design of the packaging.
Cardiac Medical Devices
The design and manufacture of cardiac medical devices present special challenges. The devices play a crucial role in maintaining the lives of patients, which mean they must be completely reliable, sometimes over extended periods of time. Other challenges can include the complexity of the devices and their delicate nature. To ensure devices meet the highest levels of performance, international standards and US regulations have been developed. Proven Process has the experience, capacity, and facilities to design and developed cardiac medical devices and a proven track record of bringing such devices to market.
Proven Process has developed some of the most innovative cardiac devices on the market today. The breadth of our technological experience gives our customers' products the clinical advantage needed to succeed in today's medical device marketplace. For over 17 years, Proven Process has successfully developed a broad portfolio of cardiac devices for our customers including:
- Cardiac assist devices and drivers
- Implanted and external cardiac monitoring devices
- Implanted cardiac rhythm management devices
- Robotic systems for electrophysiology
- Wireless programmers for implantable pacemakers and defibrillators
- Interventional vascular access devices and disposable sterile accessory kits
- Ultrasound vascular access assist equipment
We provide a wide range of development and manufacturing services specifically for cardiac devices including:
- Implantable and other advanced medical data acquisition and signal
- Medical grade software development
- Precision motion control
- Advance interconnection technology
- Complex electro-mechanical system assembly
- Hermetic packaging design and process qualifications
- Biocompatible material selection expertise for implantable devices and catheters
- High speed near field wireless telemetry design experience
- Physiologic control algorithms
- Sterile and non sterile commercial assembly and manufacturing